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Cra (Level I, Level Ii And Sr Cra)

Thermo Fisher Scientific
Thermo Fisher Scientific
2-6 years
Not Disclosed
10 Dec. 29, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Research Associate (CRA) – Level I, II & Senior CRA (Remote, India)
Location: India (Remote)
Employment Type: Full-Time
Experience Required: Level I – 2+ years, Level II – 4+ years, Senior CRA – 6+ years in clinical monitoring

About Thermo Fisher Scientific – Clinical Research Services:
Thermo Fisher Scientific is a global leader in scientific research and clinical development, driving innovation in drug discovery and delivery across 100+ countries. Our Clinical Research Services, powered by the PPD® portfolio, provide end-to-end support for clinical trials—from study startup, monitoring, and oversight to study closeout. We partner with global pharmaceutical, biotechnology, and healthcare organizations to ensure high-quality, compliant, and efficient clinical studies that improve patient outcomes worldwide.

Position Overview:
The Clinical Research Associate (CRA) is responsible for monitoring investigational sites and ensuring compliance with protocols, ICH-GCP guidelines, regulatory requirements, and SOPs. The CRA performs on-site and remote monitoring, manages documentation, assesses data integrity, and contributes to trial quality and audit readiness. This role requires critical thinking, problem-solving skills, and a proactive approach to identifying and mitigating site risks.

Key Responsibilities:

  • Conduct on-site and remote monitoring visits to assess protocol adherence, regulatory compliance, and data integrity.

  • Perform risk-based site monitoring, identify deviations, and implement corrective and preventive actions.

  • Review and verify study data, including source data verification (SDV), case report forms (CRFs), and investigational product accountability.

  • Maintain accurate and timely documentation of site observations, deviations, and resolutions.

  • Collaborate with investigational sites, project teams, and clients to ensure trial objectives are met.

  • Support investigator site selection, initiation, and closeout activities.

  • Facilitate communication between sites, clients, and internal teams to resolve trial-related issues efficiently.

  • Participate in audit and inspection readiness, providing support during regulatory inspections.

  • Maintain compliance with clinical trial management systems, reporting tools, and project documentation standards.

  • Contribute to process improvement initiatives, project publications, and team knowledge sharing.

Qualifications and Skills:

  • Bachelor’s degree in Life Sciences, Nursing, or related field; relevant certifications preferred.

  • Valid driver’s license where applicable for on-site monitoring.

  • Strong understanding of ICH-GCP guidelines, clinical trial regulations, and SOPs.

  • Proven clinical monitoring skills across multiple therapeutic areas.

  • Ability to conduct root cause analysis, risk-based monitoring, and problem-solving.

  • Excellent verbal and written communication skills in English.

  • Proficient in Microsoft Office Suite and clinical trial management software.

  • Strong organizational, time management, and interpersonal skills.

  • Ability to work independently, as well as part of a multidisciplinary team.

Experience Requirements by Level:

  • CRA Level I: Minimum 2+ years of clinical monitoring experience.

  • CRA Level II: Minimum 4+ years of clinical monitoring experience.

  • Senior CRA: Minimum 6+ years of clinical monitoring experience with extensive exposure to protocol compliance and site management.

Work Environment:

  • Remote work with independent travel up to 30–40% (varies by assignment) for on-site visits, including automobile, airplane, or train travel.

  • Exposure to healthcare and laboratory environments as part of site monitoring activities.

  • Ability to perform under pressure while managing multiple sites and priorities.

Why Join Thermo Fisher Scientific:

  • Be part of a global CRO delivering life-changing therapies across diverse therapeutic areas.

  • Engage in challenging, meaningful work that impacts health outcomes worldwide.

  • Access to professional development, advanced clinical research technologies, and collaborative project teams.

Equal Opportunity Employer:
Thermo Fisher Scientific is committed to providing equal employment opportunities to all qualified candidates regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, or veteran status. Reasonable accommodations are available during the hiring process for candidates with disabilities.

Application Instructions:
Qualified candidates are invited to submit their CV and cover letter through the Thermo Fisher Scientific careers portal, highlighting relevant clinical research monitoring experience and therapeutic area expertise.